metal impurities pose risks to human health as well as to the quality and
efficacy of pharmaceutical products. Recent changes to regulatory guidelines
require the specific quantitative analysis of pharmaceutical products using
ICPOES or ICP-MS. USP <232> Elemental Impurities – Limits, USP
<233> Elemental Impurities – Procedures, and Ph.Eur. Chapter 5.2 align
with ICH Q3D.'
We have developed a set of certified reference
materials to perform each of the requirements for USP <232>/ICH Q3D
compliance that are traceable directly to the National Institute of Standards
and Technology (NIST) SRMs. Each of the standards that LGC produces for USP
<232> and ICH Q3D compliance meets the stringent requirements of ISO
17034 and ships with a comprehensive Certificate of Analysis.
We offer a complete CRM kit for the entire
range of target elements, including an internal standard optimised for this
application. LGC Standards can also provide you with single element standards
for your specific needs.